Kröber aeroplus E User manual

16
Instructions for Use
aeroplus E

aeroplus E
Preliminary statement
2
Kröber Medizintechnik GmbH
Salzheck 4
D-56332 Dieblich
Deutschland
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
Internet: www.kroeber.de
Dok-ID: TD071608 R5
Version: 21.08.2019

aeroplus E
Preliminary statement
3
1 Preliminary statement ............................................................................................................... 5
2 General ..................................................................................................................................... 6
2.1 Information in these instructions for use...................................................................................... 6
2.2 Type plate ...................................................................................................................................... 6
2.3 Liability and warranty .................................................................................................................... 6
2.4 Explanation of symbols.................................................................................................................. 7
2.5 Copyright protection ..................................................................................................................... 7
2.6 Return and waste disposal ............................................................................................................ 8
2.7 Customer service ........................................................................................................................... 8
3 Safety........................................................................................................................................ 9
3.1 General .......................................................................................................................................... 9
3.2 Customer’s responsibility .............................................................................................................. 9
3.3 Intended use.................................................................................................................................. 9
3.4 Contraindications......................................................................................................................... 10
3.5 Dangers which may arise from the device .................................................................................. 11
3.6 Behaviour in case of hose fire ..................................................................................................... 14
4 Design and function ................................................................................................................. 15
4.1 General description ..................................................................................................................... 15
4.2 Design .......................................................................................................................................... 15
5 Technical data.......................................................................................................................... 17
6 Transport, packaging and storage............................................................................................. 18
6.1 Transport inspection.................................................................................................................... 18
6.2 Storage......................................................................................................................................... 18
7 Taking into service ................................................................................................................... 19
7.1 Before assembling ....................................................................................................................... 19
7.2 Choosing the location.................................................................................................................. 21
7.3 Installing the humidifier stand..................................................................................................... 22
7.4 Assembly...................................................................................................................................... 23
8 Operation................................................................................................................................ 27
8.1 Taking into service –switching on............................................................................................... 27
8.2 Setting the oxygen volume flow .................................................................................................. 30
8.3 Taking out of service –switching off ........................................................................................... 32
8.4 Abnormal conditions ................................................................................................................... 32
8.4.1 Alarm priorities ..................................................................................................................... 33
8.4.2 Alarme................................................................................................................................... 33
9 Maintenance ........................................................................................................................... 37
9.1 Safety ........................................................................................................................................... 37
9.2 General notes .............................................................................................................................. 37
9.2.1 Cleaning................................................................................................................................. 37
9.2.2 Disinfection ........................................................................................................................... 37
9.3 Maintenance schedule ................................................................................................................ 38
9.3.1 Hospital / out-of-hospital use ............................................................................................... 38
9.3.2 With changing patients ......................................................................................................... 39
9.3.3 Following a Technical Service ............................................................................................... 39

aeroplus E
Preliminary statement
4
9.3.4 Life time................................................................................................................................. 40
9.4 Maintenance ................................................................................................................................ 40
10 Spare parts and accessories .................................................................................................... 42
11 Symbols ................................................................................................................................. 43
11.1.1 Recommended safety distances ......................................................................................... 45

aeroplus E
Preliminary statement
5
1 Preliminary statement
Your doctor has found that you require an additional oxygen supply. With the aeroplus E you
received a German brand product for oxygen supply, which has been developed on the basis
of the latest knowledge in both medical engineering and electronics. Permanent quality
inspections ensure uniform quality on the highest level.
The aeroplus E is a highly reliable oxygen concentrator, intended for use in homes or at
home, as well as for clinical applications.
However, should problems arise with the aeroplus E, you may contact your dealer at any
time.
This medical care product from Kröber is labelled with the CE-sign according to MDD
(Medical Device Directive).
Only use the aeroplus E after a medical indication and only in compliance with the
doctor's orders by following these instructions for use.
If side effects or extreme health restrictions occur during the therapy, you should
immediately consult your doctor.

aeroplus E
General
6
2 General
2.1 Information in these instructions for use
This instructions for use describes the installation, operation and maintenance of the device.
Strict compliance with the stated notes on safety and instructions for use is a prerequisite for
safe and proper work with the device.
Moreover, compliance with the accident prevention instructions valid at the location of use
and the general safety regulations is mandatory.
This instruction manual is part of the product and should be kept near the device so that it is
at any time available for personnel involved in installation, operation, maintenance and
cleaning.
The graphic illustrations in this manual may perhaps differ slightly from the actual design of
the device.
2.2 Type plate
The type plate of the aeroplus E is attached to the back of the device above the coarse dust
filter.
2.3 Liability and warranty
All details and notes for the operation, maintenance and cleaning of the device are made to
the best of our knowledge taking into consideration our experience and knowledge gained up
to now.
We reserve the right to make technical changes to the machine dealt with in these
instructions for use within the context of ongoing development.
Translations are also carried out to the best of knowledge. We do not accept any liability for
errors in translation. The German version of the instructions for use, which is also delivered
with the device, is the definitive version.
Texts and illustrations do not necessarily correspond to the scope of delivery. The drawings
and graphics are not to scale 1:1.
Read instructions for use carefully before starting operation of the device!
The manufacturer will not assume liability for damage or disruptions that occur as a result of
non-compliance with the instructions for use.
Handing over these ins tructions for use to third parties is notpermit ted andr esults in the obligatio nf orc ompensation

aeroplus E
General
7
2.4 Explanation of symbols
Important safety and equipment related notes in these instructions for use are highlighted by
symbols. These notes must be strictly adhered to in order to avoid accidents, personal
injuries and damage to property.
WARNING!
This symbol warns of dangers that can lead to adverse effects on health,
injuries, permanent physical damage or to death.
Strictly comply with all notes regarding work safety, and be particularly careful in
these situations.
WARNING! Danger of electric current!
This symbol draws attention to dangerous situations involving electrical
currents. There is a danger of serious injury or death if the safety notes are not
complied with. The related work may only be carried out by qualified electricians.
ATTENTION!
Information highlighted with this symbol must be strictly complied with in order
to avoid damage to the machine, malfunction and/or breakdown.
NOTE!
This symbol highlights hints and information to be observed for efficient and non-
disrupted operation of the device.
2.5 Copyright protection
This instruction for use is to be treated confidentially. It should only be used by persons who
have been authorized accordingly. It may only be passed on to third parties with the written
consent of the manufacturer.
All documents are protected by copyright protection law.
It is not permissible to pass on or reproduce the documents, either as a whole or excerpts
thereof, to evaluate or communicate their content, unless explicitly entitled to do so. Any
violations are liable to prosecution and require compensation.
We reserve the right to exercise industrial property rights.

aeroplus E
General
8
2.6 Return and waste disposal
–If the device has been delivered through a parcel service and not directly by a dealer
you should keep the packaging material for possible service instances.
–If there is no corresponding agreement regarding the return of packing material, then
the packing material remains with the customer. He is responsible for environmental
waste disposal in accordance with the applicable waste disposal legislation.
–After use the device may be returned to the dealer, who is then responsible for proper
disposal of the device.
–Do not dispose of the device into the domestic household waste.
–Non-infectious used accessories (e.g. nasal cannula) can be disposed of as domestic
waste.
–Infectious accessories (e.g. nasal cannula of an infected user) must be disposed of
through a specially approved waste disposal company. Addresses are available from
your local municipality.
2.7 Customer service
Service work should normally be carried out by your local authorized dealer.
You can contact Kröber Medizintechnik GmbH as follows:
Office hours:
Mo-Thu 7.30 a.m. - 4.00 p.m., Fri 7.30 a.m. - 2.00 p.m.
Address:
Kröber Medizintechnik GmbH
Salzheck 4
D-56332 Dieblich
Germany
Phone:
[phone]
Fax:
[phone]
Internet:
www.kroeber.de
eMail:
[email protected]

aeroplus E
Safety
9
3 Safety
This section provides an overview over all important safety aspects for safe and trouble-free
operation of the device.
The individual chapter additionally contain actual safety notes highlighted with symbols,
which will help to avoid immediate dangers.
3.1 General
The machine is built according to the currently applicable rules of technology and is safe to
operate.
However, dangers may still arise from the device if it is incorrectly operated or used for
purposes it is not intended for.
Any persons using this device must have read and understood these instructions before
starting operation. This also applies if the person in question has already worked with just
such a device or similar equipment or was trained by the manufacturer.
Knowing the content of these instructions for use is a prerequisite for the avoidance of
mistakes and for safe and trouble-free operation of the device.
Neither changes nor conversions may be carried out on the equipment, which have not been
explicitly authorized by the manufacturer, to avoid dangers and to ensure optimal
performance.
All safety decals and operating signs on the device must be kept well legible at all times.
Damaged or illegible decals must be replaced immediately.
3.2 Customer’s responsibility
This instruction for use must be kept near the device, so that it is available for the user at any
time.
Apart from the notes on safety mentioned in this manual, all generally valid safety and
accident prevention instructions must also be observed and adhered to.
The machine may only be operated in a technically perfect condition and if operationally
safe.
The information contained in the instruction manual is complete and must be adhered to
without limitation.
3.3 Intended use
The operational safety of the device is only assured when used for the purpose it is intended
for, as specified in the instructions for use.
The aeroplus E concentrates the oxygen contained in the ambient air by the so-called
pressure swing adsorption process while the existing nitrogen is separated from the rest of
the intake ambient air and the rest of the mixture is provided to the patient with up to 95%
oxygen concentration and from 0.5 to 5 liters per minute.
The aeroplus E solely intended for use within the scope of a non-life sustaining medical
therapy for the additional supply of oxygen. The device may thereby be used in hospitals,
homes or at home.
The patient is intended as an operator, the operation of the device may only be done by a
previously admitted adult. The application may be performed on small children (at least 2
years) up to adults.

aeroplus E
Safety
10
ATTENTION! Danger of damage to health due to phtalate-containing accessory
components!
In many phthalates, an impairment of male reproduction is either proven or strongly
suspected. Damage to the liver, nervous system and immune system and an increase
in overweight and insulin resistance cannot be ruled out.
Phthalates can penetrate the placental barrier and damage a child in the womb.
Children in particular, whose organisms are still developing, are increasingly
absorbing phthalates from toys or floor coverings.
If children and pregnant or nursing women use this medical device, it is recommended
to use phthalate-free accessory components such as O2 tubes or nasal cannulas.
Phthalates also increase the risk of allergies and asthma in pregnant women and
children.
The device may only be used according to medical indications and only in accordance with
the medical prescription and the operating instructions.
NOTE!
To ensure the success of the therapy, the effectiveness of the therapy in relation to the set
volume flow should be checked regularly by the attending physician.
Intended use also includes following the assembly instructions and the instructions for
cleaning and maintenance of the device.
Any other use of the device beyond these limits is prohibited and is not considered as
unintended use! Claims of any kind against the manufacturer and/or his authorized
representatives resulting from damage caused by unintended use of the device are
excluded. The customer is solely liable for any damage resulting from unintended use.
This also applies to the use of non-approved application parts, such as oxygen safety
tubes, nasal cannulas and masks, other parts and accessories.
3.4 Contraindications
No contraindications are known to Kröber Medizintechnik.

aeroplus E
Safety
11
3.5 Dangers which may arise from the device
The device was subjected to a risk analysis. The resultant construction and design of the
device corresponds to the current status of technology.
However, there is still a remaining risk!
The device requires responsibly minded and cautious operation. Improper operation or
operation by unauthorized persons can endanger persons.
WARNING! Risk of health damage!
If an absolutely safe oxygen supply is required, it is strictly necessary to have a
second, independent oxygen source available as replacement (e.g. a mobile
oxygen savings system with an oxygen cylinder).
If the patient or the operator notices at any time that the available amount of
oxygen is not sufficient, you should immediately contact your dealer and/or
doctor.
WARNING! Risk of health damage!
Particular supervision is required if the device is to be used in the vicinity of
children or bedfast persons. The device must under no circumstances be used
with children without additional supervision!
WARNING! Small parts, choking hazard!
Contains small parts (e.g. FireSafe- check valve), keep away from children!
WARNING! Danger of side effects!
Do not modify your device. You can endanger your health.
Do not remove or open any covers (besides the coarse dust filter and service
compartment cover.
WARNING! Risk of health damage!
Geriatric, pediatric or any other patients unable to communicate discomfort can
require additional monitoring and or a distributed alarm system to convey the
information about the discomfort and or the medical urgency to the responsible
care giver to avoid harm.
WARNING! Risk of side effects!
If side effects or extreme health restrictions occur during the therapy, you
should immediately consult your doctor.

aeroplus E
Safety
12
Under certain conditions, an oxygen therapy may be dangerous. Before using
the aeroplus E, consult a physician.
To ensure receiving the therapeutic amount of oxygen delivery according to your
medical condition the aeroplus E must
–be used only after one or more settings have been individually determined
or prescribed for you at your specific activity levels.
–be used with the specific combination of parts and accessories that are in
line with the specification of the concentrator manufacturer and that were
used while your settings were determined.
WARNING! Fire hazard caused by oxygen!
Oxygen is vital, but in concentrators with only a few percentage points above the
normal oxygen content in the air it is a highly dangerous fire accelerant. There
are only a few materials which will not burn off like an explosion under a raised
concentration of oxygen.
Therefore:
–Oxygen may only be handled by trained or specially instructed persons!
–The misuse of oxygen, e.g. to cool down or improve the ambient air, to cool
down and dust or blow off of persons, clothes, furniture etc. is dangerous
and therefore prohibited!
–Follow all mandatory instructions for installing and use of fire-reducing
equipment such as the metal connector a1nd FiresafeTM check valve.
–Smoking during oxygen therapy is dangerous and is likely to result in facial
burns or death. Do not allow smoking within the same room where the
oxygen concentrator or any oxygen carrying accessories are located.
If you intend to smoke, you must always turn the oxygen concentrator off,
remove the cannula and leave the room where either the cannula or mask
or the oxygen concentrator is located. If unable to leave the room, you must
wait 10 minutes after you have turned the oxygen concentrator off before
smoking.
–There is a risk of fire associated with oxygen enrichment during oxygen
therapy. Do not use the oxygen concentrator or accessories near sparks or
open flames.
–Open flames during oxygen therapy are dangerous and is likely to result in
fire or death. Do not allow open flames within 2 m of the oxygen
concentrator or any oxygen carrying accessories.
–After having stayed in a possible oxygen saturated atmosphere you should
thoroughly aerate your cloths, because oxygen adheres to the clothes very
well! An ignition source, e.g. a burning cigarette, could easily cause
burning of your clothes.
–Materials that do not burn in air may burn very vigorously and even
spontaneously in oxygen or oxygen enriched air. This already applies for
an enrichment of only a few percent!
–Use only water-based lotions or salves that are oxygen-compatible before
and during oxygen therapy. Never use petroleum or oil-based lotions or
salves to avoid the risk of fire and burns”

aeroplus E
Safety
13
–Do not lubricate fittings, connections, tubing, or other accessories of the
oxygen concentrator to avoid the risk of fire and burns!
–Oxygen considerably increases the temperature of a flame and the speed of
combustion!
–Do not fill the humidifier with flammable fluids!
–Oxygen makes it easier for a fire to start and spread. Do not leave the nasal
cannula or mask on bed coverings or chair cushions, if the oxygen
concentrator is turned on, but not in use; the oxygen will make the
materials flammable. Turn the oxygen concentrator off when not in use to
prevent oxygen enrichment.
WARNING! Danger of electric current!
Electric energies can cause severe injury. Damaged insulation or components
cause a danger to life.
Therefore:
–Work on the equipment must only be performed by trained professionals.
–Pull the mains plug out before starting work on the device!
–Check mains leads for damage before every use.
ATTENTION! Observe high frequency safety!
Medical equipment can be influenced by (mobile) HF communication equipment
(e.g. mobile phones).
Do not use mobile radio equipment in the vicinity of the aeroplus E.
ATTENTION! Observe electromagnetic compatibility!
Electrical medical equipment is subjected to stringent protective measures
concerning electromagnetic compatibility (EMC) and must be installed and
operated in accordance with the EMC information contained in the
accompanying documents. The following should be noted in particular:
–Floors should be made of wood or concrete or should be covered with
ceramic tiles. If the floor is covered with a synthetic material, the relative
humidity must be at least 30%.
–During operation the device must therefore not be exposed to extremely
strong magnetic fields.
–Magnetic fields at mains frequency must comply with the typical values
found in business or hospital environments.
ATTENTION! Keep the minimum distance!
The air intake of the aeroplus E is located on the back side of the device, the
following is therefore of importance:
–Place the aeroplus E oxygen concentrator in a well ventilated place.

aeroplus E
Safety
14
–There should be a minimum distance of 30cm from walls, curtains and
other large objects (e.g. cupboards), so that an unrestricted entry of air is
assured at the back of the device.
–The aeroplus E oxygen concentrator must not be used directly beside or
even stacked with other equipment.
ATTENTION! Avoid overheating!
The device is air cooled, in order to avoid overheating it must not be placed near
heaters, etc.
ATTENTION! Oxygen pollution!
Only install the oxygen concentrator in places without impairment by air quality
or smoke.
ATTENTION! Ensure simple separation of the device!
Install the device in such a way that an all-pole separation by pulling the mains
power supply cable can easily be made at all times!
ATTENTION! No maintenance during regular operation!
Do not perform a service or maintenance routine while a patient needs the
device!
ATTENTION! Accessories containing phtalats!
If children, pregnant or breastfeeding women use the aeroplus E, it is
recommended to use phtalat-free accessories such as O2 hoses or nasal
cannulas. Phtalats are known to increase the risk of allergies and asthma.
ATTENTION! System building!
The responsible organisation is also responsible for the compatibility of all
components of the system. This has to be checked prior to the initial use of the
systems.
3.6 Behaviour in case of hose fire
If, despite all precautions, a hose fire should occur, it is not sufficient to switch off the device,
as oxygen will continue to flow for some time after it has been switched off.
The following steps are necessary:
- Disconnect the oxygen hose from the device to interrupt the oxygen supply.
- Suffocate the flames (e.g. with a blanket).
- After extinguishing the fire, ventilate well, as toxic gases are produced when the PVC hose
burns.
The metal connection at the oxygen outlet acts as a fire brake so that the flames cannot
spread into the device.

aeroplus E
Design and function
15
4 Design and function
4.1 General description
The aeroplus E oxygen concentrator for has been optimized for the oxygen supply at home.
The aeroplus E concentrates the oxygen of the room air by applying the pressure swing
adsorption process, by removing the nitrogen portion of the room air. The remaining gas
contains up to 95% pure oxygen and is supplied to the patient with up to 5 liter per minute.
4.2 Design
Setup:
1Carrying handle
2O2 flowmeter
3Control panel
4Casters
5Mounting bracket for humidifier
6Filter lid
7Device inlet filter (behind filter lid) and air inlet
8USB service connection (behind filter lid)
WARNING! Risk of device
malfunction!
Connect only authorized devices to this
port for service means
9Mains power cable
10Air exhaust
1
2
3
4
8
6
6
9
10
7

aeroplus E
Design and function
16
Display and control panel:
11 O2 connector: connects with nasal cannula or oxygen safety hoses; supply of concentrated
O2
12Mains power failure LED: activated in case of mains power loss.
13Mains LED: permanently activated during operation of the device; flashes during the initial
starting phase when the oxygen concentration has yet not reached the guaranteed
specifications for oxygen purity
14 Mains power switch: switches the concentrator on and off
15 Alarm tone mute key: mutes the alarm sound for 20 seconds.
16 Symbol „consult instruction for use“
17 Technical error LED: activated in case of technical fault; always in combination with LCD
error code.
18 O2 error LED: activated in case of low oxygen concentration
19 LC display: displays operating hours and error codes.
20O2 flowmeter: sets the volume flow
20
11
12
13
14
15
16
17
18
19

aeroplus E
Technical data
17
5 Technical data
Model
aeroplus E
Classification acc. to MPG
IIa, rule 11
Operating voltage
230 V, 50 Hz
Storage- and Transport
Conditions
Storage and transport temperature: -25 to +70 °C
Relative humidity: 15% - 93 % (r.H. non-condensing)
Air pressure: 700 to 1060 mbar
Ambient operating conditions
Operating temperature: +5 to +40 °C
Storage and transport temperature: -25 to +70 °C
Humidity: 15% - 93 % r.H., non-condensing (Operation,
Storage and Transport)
Pressure: 700 - 1060 mbar (Operation, Storage and Transport)
Sound power level
38,6 dB(A) 2
Power rating
295 W
Fuses
1 x T3.15A H 250 V, 5 x 20 mm
1 x T1.0A, L 250 V, 5 x 20 mm
Temperature fuse compressor compartment 84°C
Weight
17,5 kg
Dimensions (HxWxD)
60 x 29 x 40 cm
O2 purity
0,5 bis 4 l/min. 93 % +/- 3 %
4 bis 5 l/min. 90 % +/- 3 %
O2 purity measurement is implemented internally under die
a.m. operating conditions
min. recommended volume
flow 1
0.5 l/min
max. recommended volume
flow 1
5 l/min
Volume flow ( @ 5l/min) 1
@ 0 kPa pressure: 5 l/min
@ 7 kPa pressure: min. 4.8 l/min
max. outlet pressure:
60 kPa (normal state), 275 kPa (single fault)
IP-classification
IP 21
1According to ISO 80601-2-69 the sound pressure level of the aeroplus E is 40,1dB(A) @ 3l/min and 40,3dB(A) @ 5l/min. The
sound power level is 56.3dB(A) @ 3l/min and 56.6dB(A) @ 5l/min.
2Data according to test method 14-1 03/2007 MDS-Hi, quality requirement for inclusion in the catalogue of therapeutic products
and aids
3Volume flow @ room temperature and –pressure, dry air.

aeroplus E
Transport, packaging and storage
18
6 Transport, packaging and storage
The following should be noted when transporting the aeroplus E:
–The device should only be shipped and transported in its original packaging.
–For transport, e.g. by car, the device may stand upright or lay on one of the two
large flat sides.
–Open the transport box from the top. Do not stand the transport carton upside
down or on one of its narrow sides.
6.1 Transport inspection
It is highly recommended to check the complete delivery for completeness and possible
transport damage, immediately after receipt.
In case of externally detectable transport damage you should not accept the delivery, or only
with reservation. Acknowledge the receipt only with reservation (e.g. on the freight
document). Specify the expected damage and inform the manufacturer immediately.
Hidden damage should be claimed immediately after detection, because damage claims can
only be lodged within the applicable claims periods.
The packaging material should be stored; it may be needed if the device has to be returned.
6.2 Storage
If the package is to be stored before it is taken into service, please observe the following
instructions:
–Store in a dry environment. Relative humidity: max. 93 % without condensation.
–It must be assured that the package is not stored outdoors.
It must also be assured that the floor used for storage is dry over the entire storage
period.
–Storage temperature -25 to +70°C.
–Store in a dust-free environment.
–Avoid mechanical shocks and damages.
6.3 Acclimatisation times
Adequate acclimatization times must be observed if the device is exposed to large
temperature fluctuations in order to avoid the formation of condensation water. Also note that
acclimatization times may vary depending on temperature and humidity. Possible
acclimatization times can be found in the table below:
Temperature difference in
°C
Time in hours
Temperature difference in
°C
Time in hours
10
1
40
4
20
2
50
5
30
3
60
6

aeroplus E
Taking into service
19
7 Taking into service
7.1 Before assembling
Check before assembling whether all components needed for correct operation are available.
NOTE!
Contact the manufacturer or the local service provider if help is needed during
operation or maintenance. The address of the manufacturer can be found on page 8.
The a.m. organization should also be contacted in case of unexpected events or
incidents.
NOTE!
After unpacking the device, the transport or storage temperature may have to be adjusted
to the operating temperature. Before switching on the device, please observe the waiting
times specified in section 6.3 (Acclimatization times).
Device:
•aeroplus E incl. these
instructions for use
Mounting bracket for
humidifier incl. screw (left)
Humidifier (right)

aeroplus E
Taking into service
20
Oxygen nasal cannula
2m (left)
Oxygen nasal cannula
5m (right)
Firesafe check valve (left)
2 pcs O2safety hose
0.33m (right)
O2safety hose 15m
operational setup
a. Oxygen
concentrator
b. 0.33 m safety hose
c. Humidifier holder
d. Humidifier
e. Mounting strips
f. 15m O2 safety hose
g. Firesafe valve
h. 2 m oxygen nasal
cannula